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Public Comments on “Proposed Changes to the NIH Guidelines for Human Stem Cell Research and the Proposed Scope of an NIH Steering Committee’s Consideration of Certain Human-Animal Chimera Research”

On August 5, 2016, the National Institutes of Health (NIH) published in the Federal Register and the NIH Guide to Grants and Contracts a proposal to increase oversight and expand current prohibitions in research with certain animal models containing human cells. First, NIH is establishing a steering committee to provide an additional layer of oversight for NIH funding considerations in this field of research.  Second, NIH is proposing to revise the NIH Guidelines for Human Stem Cell Research to include additional restrictions for NIH funding. Further information about the proposed changes are described in a blog by Carrie D. Wolinetz, Ph.D., Associate Director for Science Policy, NIH.

NIH specifically requested public comment on:

  1. The proposed scope of research (e.g., grant applications, contract proposals, intramural research protocols, etc.) to be considered by an NIH steering committee to provide programmatic input to the director of the relevant Institute or Center (or equivalent NIH official responsible for funding decisions).  The NIH proposed the scope of research include research in which:

    a. human pluripotent cells are introduced into non-human vertebrate embryos, up through the end of the gastrulation stage, or

    b. human cells are introduced into post-gastrulation non-human mammals (excluding rodents), such that there could be either a substantial contribution or a substantial functional modification to the animal brain by the human cells.

  2. A proposal to revise the NIH Guidelines for Human Stem Cell Research to expand the existing prohibition on introducing human pluripotent stem cells into blastocyst stage nonhuman primate embryos to include pre-blastocyst stage nonhuman primate embryos; and to expand the prohibition on research involving the breeding of animals where the introduction of hESCs or human induced pluripotent stem cells may contribute to the germ line to include any human cells that may result in the formation of human gametes.

The public comments are available below: